The vaginal diaphragm, as currently designed, has been used since the beginning of the 19th century for the prevention of fertilization. The vaginal diaphragm was invented, following the invention of the vulcanization of rubber, by Freidrick Wilde in 1832. However, credit for its invention is usually and erroneously given to C. Hasse. In 1882, Hasse, fearful that his professional and academic reputation would be jeopardized by his publishing an article pertaining to the vaginal diaphragm, titled "Ueber Faculative Sterililat", published the article under the pseudonym, Wilhelm P. J. Mensinga. This paper on "facultative sterility", FS, was a treatise in support of controlling fertility and it listed three inidcations for using "facultative sterility". The indications were (1) permanently in the case of incapacity to bear children, (2) for a longer undetermined period of time in case of syphilis and other constitutional diseases, and (3) for a definite period of time as in cases concerning a failure of lactation. Shortly after the work of Hasse became known, the vaginal diaphragm became popular in both Europe and in the United States, and to this day Wihlem Mensinga is credited with inventing the vaginal diaphragm in 1882.
Many attempts have been made by the prior art to increase the effectiveness of the vaginal diaphragm. For example, in U.S. Pat. No. 2,551,618 the patentee Mayer discloses a pessary of the vaginal diaphragm type consisting of a cup-shaped body having an annular wall with the improvement consisting of a solid, substantially conical stud for insertion into the cervical orifice. The stud is used in an orifice-closing relation with the uterus for sanitary and hygienic purposes. U.S. Pat. No. 2,580,133 issued to Sheen discloses a pessary-diaphragm that is useful for treating infections at the orifice of the uterus. The treatment consists in placing a medicament in the cavity area of the pessary-diaphragm, which cavity is positioned over the cervical orifice to achieve the intended result. U.S. Pat. Nos. 4,198,976; 4,200,090; and 4,219,016 issued to Dorbish et al disclose a vaginal contraceptive device consisting of a dish-shaped reservoir containing a spermicide for releasing into a vagina for achieving contraception. U.S. Pat. No. 4,286,593 issued to Place et al discloses a vaginal contraceptive shield comprising a rod-like support containing a spermicide for releasing in a vagina. U.S. Pat. No. 4,326,510 issued to Buckles discloses a vaginal barrier contraceptive torus consisting of a pair of overlapping, unsealed flaps for letting fluid drain from the cervix and for releasing a spermicide for its known effects. U.S. Pat. No. 4,332,243 issued to Gutnick discloses a contraceptive diaphragm consisting of a pouch or sac, and individual, refillable chambers inside a rim, which release an active agent from the chambers and then through the rim for preventing disease and for preventing conception.
While the above vaginal, physical contraceptives seemingly represent advancements in the vaginal contraceptive art, there are serious disadvantages associated with both their design and their use. For example, the vaginal diaphragms disclosed in the above identified U.S. Pat. Nos. 2,551,618; 2,580,133; 4,198,976; 4,200,090; and 4,219,016 are not a reliable method of birth control in view of the scientific evaluation presented in an article titled, "Why The Diaphragm Doesn't Work", as published by Berkowitz in San Francisco, Vol. 23, No. 12, pages 72, 74 and 75, 1981. In view of the article, these diaphrams are not reliable because for a diaphragm to block the passage of sperm, the diaphragm must be fitted approximately to the diameter of the vagina near the opening of the cervix. Thus, since only a minute amount of ejaculate is needed for fertilization, and since the shape of the vagina varies during intercourse and orgasm, it is easy for a sperm to swim around the diaphragm and gain access to the opening of the cervix. This can lead to an unwanted fertilization, as there is a margin of error built into the concept of the diaphragm. The contraceptive shields as disclosed in U.S. Pat. Nos. 4,286,593 and 4,326,510 possess the structural disadvantage that they may lose contact with the walls of the vagina, as the vagina expands during sexual excitement, and the shield may be displaced concomitantly. These in vivo activities make it possible for a sperm to travel around the shield and gain entrance into the uterus. The vaginal diaphragm disclosed in U.S. Pat. No. 4,332,243 consisting of a sac or chambers that release into a rim are cumbersome to manufacture, it is difficult to refill the chambers, and the presence of the chambers precludes the diaphragm from being made with a tension member that is needed in many instances for manufacturing the diaphragm in proper position in the the vagina.
It will be appreciated by those skilled in the art, that if a vaginal diaphragm is provided that can cover the cervix and concomitantly deliver a vaginally acceptable useful agent around the entrance of the cervix, such a diaphragm would have a positive value and satisfy a long-felt need. Likewise, it will be further appreciated that if a method is provided that uses an occlusive diaphragm that delivers a useful agent for preventing fertilization, and/or lessening the possibility of acquiring a social disease, such a method would represent a substantial contribution and advancement in the practicing art.